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Dimension® Penta and Dimension® Garant L are both polyvinyl siloxane impression material, composed of a base paste and catalyst, used to make impressions of inlay, onlay, crown and bridge preparations, and edentulous jaws. Polyvinyl Siloxane Adhesive is intended to assure adhesion of impression material to the impression tray and to avoid deformation during impression taking.

Dimension® Penta and Dimension® Garant L are both polyvinyl siloxane impression material, composed of a base paste and catalyst. Polyvinyl Siloxane Adhesive is an adhesive material.

This document is a 510(k) summary for material modifications to dental impression materials and an adhesive, not a study involving a medical device with an algorithm or AI. Therefore, most of the requested fields are not applicable.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This document describes physical and performance characteristic comparisons to predicate devices, but does not detail the sample sizes for these tests. The provenance is from ESPE, a German company (submission by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany). All data would be prospective testing of the modified materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. Ground truth, in the context of expert consensus, is not relevant here as this is about physical and performance characteristics of materials tested against established standards and predicate devices.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods are relevant for subjective assessments, typically in imaging or diagnostic studies. This document describes objective material property testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI or algorithm-based device.

7. The type of ground truth used

• Established Standards and Predicate Device Performance: For Dimension® Penta and Dimension® Garant L, the "ground truth" is defined by the technical requirements of relevant DIN, ISO, and ADA standards for impression materials. For Polyvinyl Siloxane Adhesive, the "ground truth" for comparison is the performance of the predicate device, Permagum® Adhesive.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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